A Multicenter, Parallel, Blinded, Randomized Comparison of the Safety and Efficacy of Balloon Angioplasty Plus Intraluminal SBCV To Balloon Angioplasty Alone for Treatment of Stenosis or Occlusion Within the Femoropopliteal Artery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 16
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.
详细描述
This first-in-human study will evaluate the safety and effectiveness of a novel adjunctive therapy, SBCV, used with balloon angioplasty as compared to balloon angioplasty plus a control agent (saline) when used for the treatment of stenosis within the femoropopliteal artery. Effectiveness will be measured by late lumen loss at 24 weeks post treatment as evaluated by an independent, blinded core lab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for balloon angioplasty for stenosis of femoropopliteal lesion(s)
- •Rutherford Clinical Category 1-4 (claudication or critical limb ischemia)
- •Lesions are ≥70% stenosis by visual estimate
- •A patent inflow artery free from significant lesion
- •At least one patent native outflow artery to the ankle
排除标准
- •History of haemorrhagic stroke within 3 months of screening
- •History of myocardial infarction, thrombolysis or angina within 2 weeks of screening
- •Renal failure or chronic kidney disease
- •Severe calcification that renders the lesion undilatable
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: through 24 weeks
The composite of no all-cause perioperative (≤30 day) mortality and none of the following events at 24 weeks following treatment: * Index limb amputation (above or below the ankle) * Index limb re-intervention * Index-limb-related death
Late Lumen Loss
时间窗: 24 weeks
LLL is defined as the difference between the minimum lumen diameter (MLD) immediately post-primary procedure and the MLD at follow-up as measured by an independent, blinded core lab.
次要结局
未报告次要终点